GSK has announced that it has licensed its M72/AS01E tuberculosis vaccine candidate to the Gates Medical Research Institute, paving the way for continued development and potential use of the tuberculosis vaccine candidate in low-income countries with high TB burdens.
There is no approved tuberculosis vaccine capable of preventing pulmonary TB disease in adolescents and adults, who accounted for 89% of people who fell ill with TB in 2018. The live attenuated vaccine, Bacille Calmette-Guerin (BCG), has been in use for nearly a century, and while it is effective in preventing severe TB disease in infants and young children, it provides limited protection against pulmonary TB in adolescents and adults.
TB is the world’s deadliest infectious disease, with 10 million new cases and 1.5 million deaths in 2018 alone. The burden of disease is concentrated with over 97% of reported TB cases occurring in low- and middle-income countries.
Recently published final results of a phase IIb trial in South Africa, Kenya and Zambia conducted in partnership with IAVI showed that M72/AS01E had an acceptable safety profile and reduced cases of TB in HIV-negative adults with latent TB infections by half. The Gates MRI will lead vaccine candidate development and sponsor future clinical trials. GSK will provide the AS01 adjuvant for this development programme.
Dr. Thomas Breuer, Chief Medical Officer of GSK Vaccines, commented: “At GSK, we are very proud to have developed a TB vaccine candidate which has shown promising clinical trial results in adolescents and adults where the need to combat the TB epidemic is greatest. We are delighted to announce this ambitious collaboration to enable key partners to further build on and progress our scientific innovation.”
Philip Thomson, President, Global Affairs at GSK, said: “Today’s new agreement signals a new and exciting phase in our efforts to improve global public health through medical innovation. For us, this type of alliance means we can take a more sustainable approach to global health, focusing our efforts and expertise on science and research, while partnering with others to ensure their development and delivery.”